Full Opinion (html_with_citations)

Case: 21-40157      Document: 00516142688         Page: 1    Date Filed: 12/22/2021




           United States Court of Appeals
                for the Fifth Circuit                            United States Court of Appeals
                                                                          Fifth Circuit

                                                                        FILED
                                                                December 22, 2021
                                   No. 21-40157                    Lyle W. Cayce
                                                                        Clerk

   Walmart Inc.,

                                                            Plaintiff—Appellant,

                                       versus

   U.S. Department of Justice;
   U.S. Drug Enforcement Administration;
   Acting Administrator D. Christopher Evans;
   Merrick Garland, U.S. Attorney General,

                                                          Defendants—Appellees.


                  Appeal from the United States District Court
                       for the Eastern District of Texas
                               No. 4:20-CV-817


   Before Higginbotham, Smith, and Ho, Circuit Judges.
   Jerry E. Smith, Circuit Judge:
          Walmart challenges the government’s interpretation of the Con-
   trolled Substances Act,
21 U.S.C. § 801
 et seq. (“CSA”), as it applies to phar-
   macists who dispense prescription opioids. Or at least, Walmart questions
   what it says are the government’s interpretations of the CSA—it points to no
   rule, guidance, or other public document setting forth the positions it seeks
   to contest. Because it identifies no agency action, as that term is used in the
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                                      No. 21-40157


   Administrative Procedure Act (“APA”), the suit is barred by sovereign
   immunity. And even if it were not, Walmart’s failure to contradict a definite
   government position means that it has not demonstrated the existence of a
   ripe case or controversy, as required by Article III. For both reasons, we
   affirm the judgment dismissing for want of subject-matter jurisdiction.

                                           I.
          This case arises from the government’s ongoing efforts to combat the
   epidemic of opioid abuse. Opioids, legal and illegal, are regulated under the
   CSA, which is administered by the Drug Enforcement Administration
   (“DEA”). Though opioids are prescribed by doctors, those prescriptions
   must be filled by pharmacists, who may refuse to fill prescriptions that they
   deem suspicious, such as prescriptions by disreputable doctors or those
   involving certain drug combinations. Walmart dispenses prescription opi-
   oids through its pharmacies; from 2002 to 2018, it also acted as a distributor,
   shipping opioids from a distribution center to its own pharmacies.
          Walmart maintains that it has consistently taken appropriate steps to
   comply with the CSA and keep its pharmacists from dispensing opioids to
   those who should not receive them. Walmart has long allowed its pharma-
   cists to refuse to fill individual prescriptions that they believed were not legit-
   imate; it now has policies allowing pharmacists or Walmart itself categori-
   cally to refuse to fill prescriptions by individual doctors. Those policies are
   sufficiently stringent that they have provoked resistance, including adminis-
   trative investigations and warnings from state regulators as well as com-
   plaints by private-sector medical associations. Those groups generally main-
   tain that Walmart’s pharmacists are unduly intervening in the doctor-patient
   relationship and tarnishing the reputations of individual doctors, some of
   whom have filed defamation suits.
          At the same time, the Department of Justice (“DOJ”) has investi-




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                                      No. 21-40157


   gated Walmart for violations of the CSA. Despite abandoning an effort to
   bring criminal charges against Walmart, DOJ formed a working group to
   investigate Walmart for civil liability.
          Walmart thus found itself “between a rock and a hard place”—
   stringent restrictions on opioid distribution expose it to suit from state and
   private-sector actors, while lax restrictions expose it to suit from the federal
   government. To resolve this dilemma, Walmart sued under the Declaratory
   Judgment Act,
28 U.S.C. § 2201
 (“DJA”), in October 2020, requesting that
   the court make several declarations about the precise limits of pharmacists’
   obligations under the CSA. Those requested declarations are as follow:
          A. Pharmacists may be liable under the CSA and its regulations only
          when they fill a prescription that they know was not issued for a legiti-
          mate medical purpose by a prescriber acting in the usual course of the
          prescriber’s professional practice or when pharmacists knowingly
          abandon all professional norms;
          B. The CSA does not require pharmacists to second-guess a registered
          and licensed doctor’s decision that a prescription serves a legitimate
          medical purpose;
          C. The CSA and its regulations do not require pharmacists to refuse
          to fill entire categories of prescriptions without regard to individual
          facts and circumstances;
          D. The CSA and its regulations do not require pharmacists to docu-
          ment in writing why filling a prescription was appropriate;
          E. Pharmacies do not have an affirmative obligation under the CSA
          and its regulations to analyze and share aggregate prescription data
          across its stores and with line pharmacists;
          F. Pharmacies do not have an affirmative obligation under the CSA
          and its regulations to impose corporation-wide refusals-to-fill for
          particular doctors;
          G. The CSA and its regulations do not require distributors not to ship
          suspicious orders after reporting them;




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                                           No. 21-40157


           H. The CSA and its regulations did not impose monetary penalties for
           failure to report suspicious orders to DEA during the time Walmart
           self-distributed; and
           I. Defendants must follow their own regulations and may not base any
           enforceable legal positions on the alleged violation of agency guidance
           rather than obligations found in a statute or duly promulgated rule or
           regulation.
   Walmart alleges that the government takes the contrary view on all these
   proposed declarations, but it does not point to any regulations or guidance
   documents setting forth the government’s position. Indeed, Walmart avers
   that many of the positions that it challenges “contradict DEA’s own previ-
   ously expressed views.”
           Just a few weeks after the filing of this action, before the court could
   rule on Walmart’s request, the government brought a civil enforcement
   action against Walmart in the District of Delaware. 1 DOJ did in fact take ver-
   sions of the positions that Walmart challenges in this action, but Walmart
   stresses that “the issues in the two suits do not completely overlap.”2
           Meanwhile, the government moved to dismiss the present case for



           1
               United States v. Walmart Inc., No. 20-cv-1744 (D. Del. Dec. 22, 2020).
           2
               There is a second pending action that has some bearing on this one. A multi-
   district litigation case has been ongoing in the Northern District of Ohio since 2017. See In
   re Nat’l Prescription, Opiate Litig., No. 17-md-2804 (N.D. Ohio). Plaintiffs, mostly gov-
   ernment agencies, accuse numerous defendants, including Walmart, of misconduct in dis-
   pensing opioids. The Plaintiffs’ Executive Committee moved to have the present case
   transferred to that case if it is not dismissed. Because it dismissed the present case, the
   district court did not rule on the motion to transfer, and that motion is not before this court.
   We take judicial notice of the fact that on November 23, 2021, the jury returned a large
   verdict against Walmart and others. See CVS, Walmart and Walgreens Fueled Opioid Crisis,
   US jury finds,                The      Guardian (Nov, 23, 2021 3:19 PM,
   https://www.theguardian.com/us-news/2021/nov/23/ohio-cvs-walmart-and-walgreens-
   opioid-crisis.




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   want of subject-matter jurisdiction. The government maintained, inter alia,
   that Walmart’s suit was barred by sovereign immunity and that it had failed
   to identify a ripe case or controversy. After further briefing and oral argu-
   ment, the court dismissed the suit as barred by sovereign immunity. The
   court observed that to overcome sovereign immunity in this context, a plain-
   tiff must have been aggrieved by agency actions. Walmart pointed only to
   positions taken by the government during settlement negotiations, which
   were not “agency action” as that term is used in the APA, and thus its suit
   was barred. Walmart appeals.

                                          II.
          We review a dismissal for want of subject-matter jurisdiction de novo.
   Hinojosa v. Horn,
896 F.3d 305, 309
 (5th Cir. 2018). “A case is properly
   dismissed for lack of subject matter jurisdiction when the court lacks the stat-
   utory or constitutional power to adjudicate the case.” Home Builders Ass’n
   v. City of Madison,
143 F.3d 1006, 1010
 (5th Cir. 1998) (citation omitted).
   Though the district court relied exclusively on sovereign immunity, this
   court may affirm dismissal for any reason supported by the record. Ballew v.
   Cont’l Airlines, Inc.,
668 F.3d 777, 781
 (5th Cir. 2012).

                                         III.
                                          A.
          To bring a claim against a sovereign, a party must first show that that
   sovereign has waived its immunity from suit. The waiver at issue is contained
   in Section 702 of the APA. It reads in relevant part,
             A person suffering legal wrong because of agency action, or
          adversely affected or aggrieved by agency action within the
          meaning of a relevant statute, is entitled to judicial review
          thereof. An action in a court of the United States seeking relief
          other than money damages and stating a claim that an agency
          or an officer or employee thereof acted or failed to act in an




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                                           No. 21-40157


           official capacity or under color of legal authority shall not be
           dismissed nor relief therein be denied on the ground that it is
           against the United States or that the United States is an
           indispensable party.
5 U.S.C. § 702
. Most circuits that have considered the issue read the second
   sentence independently of the first, meaning that sovereign immunity is
   waived in all suits seeking equitable, nonmonetary relief against an agency. 3
   But in Alabama-Coushatta Tribe of Texas v. United States,
757 F.3d 484
 (5th
   Cir. 2014), we construed the waiver in Section 702’s second sentence as
   cabined by its first sentence.4 Thus, in this circuit, a plaintiff suing a federal
   agency must “identify some ‘agency action’ affecting him in a specific way”
   and must show that he has suffered legal wrong because of it.
Id. at 489
.
           Walmart points to two types of agency action: rules and sanctions.
   The actions it challenges do not fit neatly into either definition. We first
   address Walmart’s alleged rules, then turn to its alleged sanctions. We con-
   clude that the challenged agency conduct does not satisfy either definition,
   and so the suit is barred by sovereign immunity. Because Walmart has iden-
   tified no agency action, we do not reach the question whether it has suffered
   legal wrong because of those actions.

                                                B.
           Agencies make rules when they announce principles of general appli-
   cability and future effect.5 United States v. Fla. E. Coast Ry.,
410 U.S. 224
,


           3
             See, e.g., Trudeau v. FTC,
456 F.3d 178, 187
 (D.C. Cir. 2006); Presbyterian Church
   (U.S.A.) v. United States,
870 F.2d 518, 525
 (9th Cir. 1989); Black Hills Inst. of Geological
   Rsch. v. S.D. Sch. of Mines & Tech.,
12 F.3d 737, 740
 (8th Cir. 1994).
           4
             This circuit is not alone on its side of the split. See City of New York v. United
   States Dep’t of Def.,
913 F.3d 423, 430
 (4th Cir. 2019); SEC v. Credit Bancorp, Ltd.,
297 F.3d 127
, 141 (2d Cir. 2002).
           5
               The APA provides a longer, if sometimes unhelpful, definition of “rule”:




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                                          No. 21-40157


   244-45 (1973). Rules can be divided into substantive and non-substantive
   varieties. Substantive rules have the force of law, meaning that they bind the
   regulated public. See Texas v. United States,
809 F.3d 134, 171
 (5th Cir. 2015),
   aff’d by an equally divided court,
136 S. Ct. 906
 (2016). The APA requires that
   they be preceded by notice and comment. Id.;
5 U.S.C. § 553
. Non-
   substantive rules are those exempted from the notice-and-comment require-
   ment because they lack the force of law. They include rules governing inter-
   nal agency organization or procedures; non-binding agency policy state-
   ments; and guidance documents interpreting existing rules. See
5 U.S.C. § 553
(b)(3)(A).
           Walmart cites several “rules,” but most of them derive not from offi-
   cial publications but from positions allegedly taken by the government in set-
   tlement negotiations with Walmart. Though there is room for disagreement
   about precisely what satisfies the definition of “rule,” it surely does not
   include negotiating positions.
           As Walmart does not contest, negotiating positions are not binding on
   the regulated public and need not be preceded by notice-and-comment rule-
   making, and so they cannot be substantive rules. That conclusion comports
   with Shell Offshore Inc. v. Babbit,
238 F.3d 622
 (5th Cir. 2001), and W&T
   Offshore, Inc. v. Bernhardt,
946 F.3d 227
 (5th Cir. 2019). In both cases, the



           [T]he whole or a part of an agency statement of general or particular appli-
           cability and future effect designed to implement, interpret, or prescribe
           law or policy or describing the organization, procedure, or practice require-
           ments of an agency and includes the approval or prescription for the future
           of rates, wages, corporate or financial structures or reorganizations
           thereof, prices, facilities, appliances, services or allowances therefor or of
           valuations, costs, or accounting, or practices bearing on any of the
           foregoing . . . .
5 U.S.C. § 551
(4).




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                                         No. 21-40157


   Department of the Interior effected a policy change that, though never
   announced as a rule, “controlled” the outcome of adjudications conducted
   by the agency. Shell Offshore,
238 F.3d at 628
; accord W&T Offshore,
946 F.3d at 238
. We concluded that those policy changes were effectively rules, but
   that conclusion stemmed from the specific context in which an internal
   agency position dictated the result in a category of adjudications conducted
   by that same agency. See Shell Offshore,
238 F.3d at 628
; W&T Offshore,
   946 F.3d at 238–39. In this case, however, the negotiating positions taken by
   DOJ are mere legal theories that would succeed or fail in court based on their
   own merits. We thus agree with the parties that those positions are not sub-
   stantive rules.
           Nor can negotiating positions be thought of as non-substantive rules.
   Positions about the obligations of pharmacists are not rules of agency organi-
   zation, procedure, or practice.
5 U.S.C. § 553
(A). And because the positions
   Walmart challenges were expressed behind closed doors, they are not general
   policy statements or interpretive rules, both of which announce agency views
   to the public.6 Indeed, if Walmart is correct that negotiating positions are
   rules—despite their being not just devoid of legal force but also unwritten
   and nonpublic—it is unclear when a statement of legal opinion by a govern-
   ment agent would ever not be a rule. We reject that expansive reading of the
   definition of “rule.”
           Walmart also points to a few more definite agency statements that it
   claims are “rules,” but those statements have shortcomings of their own.
   Specifically, Walmart points to a 2007 DEA guidance letter recommending
   that opioid distributors report suspicious orders, a statement in the DEA



           6
              See Brown Express, Inc. v. United States,
607 F.2d 695
, 700–01 (5th Cir. 1979);
   Phillips Petroleum Co. v. Johnson,
22 F.3d 616
, 619–20 (5th Cir. 1994).




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                                          No. 21-40157


   Pharmacist’s Manual that pharmacists need not fill “doubtful, questionable,
   or suspicious” prescriptions, and a criminal complaint filed by DOJ arguing
   that the simultaneous prescription of certain drug combinations is never
   medically necessary. A suit based on a 2007 rule would be time-barred,
28 U.S.C. § 2401
(a), and because the guidance letter addresses only distrib-
   utors’ obligations, it would, in any case, be challenged only by Declarations
   G and H. Meanwhile, a recommendation that pharmacists not fill suspicious
   orders is far too vague to be challenged by any of Walmart’s proposed declar-
   ations. And a criminal complaint does not create rights or obligations, nor
   does it have “future effect.”7
           Even if there is substance to some of those “rules,” that is not enough
   to save Walmart’s claim under Alabama-Coushatta. In that case, the plaintiff
   did point to various permits and leases issued by the federal government.
   Alabama-Coushatta,
757 F.3d at 491
. But even a few specific actions were not
   enough to sustain a challenge “directed at the federal agencies’ broad poli-
   cies and practices.”
Id.
 Walmart’s challenge is similarly broad, and, once we
   discount the argument that a theory expressed in a settlement negotiation is
   a “rule,” the remaining rules, even if they are treated as such, are not enough
   to allow Walmart to overcome sovereign immunity. Walmart has identified
   no “rules” sufficient to meet its burden under Alabama-Coushatta.

                                                C.
           The APA’s definition of “sanction” reads,
                   [T]he whole or a part of an agency—
                   (A) prohibition, requirement, limitation, or other condition


           7
             See City of Arlington v. FCC,
668 F.3d 229, 242
 (5th Cir. 2012) (quoting Yesler
   Terrace Cmty. Council v. Cisneros,
37 F.3d 442
, 448 (9th Cir. 1994)); cf. Bowen v. Georgetown
   Univ. Hosp.,
488 U.S. 204, 216
 (1988) (Scalia, J., concurring) (stressing the importance of
   rules’ prospective nature).




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                                          No. 21-40157


                   affecting the freedom of a person;
                   (B) withholding of relief;
                   (C) imposition of penalty or fine;
                   (D) destruction, taking, seizure, or withholding of property;
                   (E) assessment of damages, reimbursement, restitution, com-
                   pensation, costs, charges, or fees;
                   (F) requirement, revocation, or suspension of a license; or
                   (G) taking other compulsory or restrictive action . . . .
5 U.S.C. § 551
(10).
           Walmart contends that “[t]hreats designed to compel compliance”8
   qualify as sanctions because they constitute “compulsory or restrictive
   action.” Applying the canon of ejusdem generis, we instead read that saving
   clause as limited to concrete actions and omissions, rather than action that is
   merely threatened.
           Ejusdem generis is a standard rule of statutory interpretation. Applying
   it, we do not read “other compulsory or restrictive action” literally but
   instead as impliedly limited to actions like the enumerated ones. We agree
   with the district court that that canon excludes contingent actions like threats
   that are distinct from the concrete actions listed.
           Walmart asks us not to apply ejusdem generis but instead to read the
   saving clause “exhaustively.”9 That alternative is unsatisfying because,


           8
             Notably, these threats overlap with the negotiating positions that Walmart char-
   acterizes as rules. Thus, under Walmart’s theory, when a government agent threatens to
   sue a regulated party under a particular legal interpretation, he promulgates a rule and
   issues a sanction. That non-distinction underscores just how far Walmart stretches the
   definition of “rule” and “sanction”—it construes both terms so generally that they
   encompass the same conduct.
           9
            The sole binding authority relied on by Walmart for that proposition is Ali v. Fed-
   eral Bureau of Prisons,
552 U.S. 214
 (2008). The Court read the phrase “any other law
   enforcement officer” literally—but it relied on the presence of the word “any,” which is
   absent here. See
id.
 at 218–19.




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                                      No. 21-40157


   without the limiting context, “compulsory or restrictive action” could in-
   clude almost anything. For instance, the passage of a statute can compel or
   restrict, but statutes can hardly be thought of as “sanctions.” Moreover,
   rules, orders, adjudication, licensing, grants of relief, and failure to act can all
   compel or restrict, meaning that “sanction” would subsume every other type
   of agency action. See
5 U.S.C. § 551
(13).
          Contrary to Walmart’s protestations, our precedents do not favor
   such a broad reading of the definition’s saving clause. In Doe v. United States,
853 F.3d 792
 (5th Cir. 2017), we did in fact read agency action broadly, doing
   so to include failure to provide the plaintiff with a means to respond to accu-
   sations against him,
id. at 800
. But we reached that result by interpreting an
   enumerated sanction, “withholding of relief,” along with two other types of
   agency action—“failure to act” and failure to grant a remedy.
Id.
 at 799–
   800. Meanwhile, Alexander v. Trump,
753 F. App’x 201
 (5th Cir. 2018),
   rested entirely on failure to act—it did not mention sanctions,
id. at 206
.
          Our precedents thus offer no basis to depart from ejusdem generis in
   reading the definition of “sanction.” We conclude that that definition does
   not extend to threats, and thus Walmart has challenged no “sanctions” as
   that term is used in the APA. Because Walmart has not satisfied Alabama-
   Coushatta’s requirement that it identify agency action, its suit is barred by
   sovereign immunity.

                                           IV.
                                           A.
          Even if this suit were not barred by sovereign immunity, Walmart
   would still have to show the existence of a case or controversy that was ripe
   for adjudication. “A declaratory judgment action is ripe for adjudication only
   where an ‘actual controversy’ exists.” Orix Credit Alliance, Inc. v. Wolfe,
212 F.3d 891, 896
 (5th Cir. 2000).




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                                       No. 21-40157


          Ripeness is a twofold inquiry that requires courts to “evaluate both
   the fitness of the issues for judicial decision and the hardship to the parties of
   withholding court consideration.” Abbott Labs. v. Gardner,
387 U.S. 136, 149
   (1967). Although the issue of fitness for decision is fact-bound and somewhat
   abstract, in the context of pre-enforcement agency action there are several
   established factors, including “whether the issue presented is a purely legal
   one, whether consideration of that issue would benefit from a more concrete
   setting, and whether the agency’s action is sufficiently final.” Ciba-Geigy
   Corp. v. EPA,
801 F.2d 430, 435
 (D.C. Cir. 1986).10 Failure on even one of
   the three prongs can render a case unfit for judicial review. See Nat’l Park
   Hosp. Ass’n v. DOI,
538 U.S. 803, 812
 (2003). In addition to those enumer-
   ated elements, courts assessing declaratory judgments often engage in more
   open-ended inquiries into the “likelihood” that threatened litigation “will
   occur.” Orix,
212 F.3d at 897
.
          In determining whether Walmart has carried its burden, we are mind-
   ful of the pendency of an enforcement action against it in the District of Del-
   aware on theories of liability similar to those Walmart challenges here. The
   existence of that litigation demonstrates that this action is not fit for judicial
   decision and also reduces any hardship posed to Walmart by abstention in
   this court. That litigation also undermines the contention that future en-
   forcement is likely. We therefore conclude that this action presents no ripe
   case or controversy.

                                            B.
          Walmart fails to show that this case is fit for judicial decision. As



          10
             Contrary to Walmart’s position, those factors govern pre-enforcement agency
   actions regardless of whether suit is brought under the APA. See, e.g., Abbott Labs.,
   387 U.S. at 138–39 (applying the factors in a declaratory action).




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                                             No. 21-40157


   noted above, Walmart does not identify any agency action; even if it had, it
   concedes that it has identified no final agency action. On the other hand,
   Walmart is correct that the declarations it requests present pure legal issues
   in that they are predominantly questions of statutory interpretation.11
   Finally, the question whether the issue would benefit from more concrete
   facts weighs in the government’s favor. For instance, it would be theoreti-
   cally possible to declare as a matter of law whether pharmacies had any obli-
   gation under the CSA to analyze data or reject certain doctors, but the ques-
   tion would be easier if the court knew exactly what obligations pharmacies
   were alleged to have and could therefore assess whether those obligations
   accorded with the governing regulations.
           This case’s lack of fitness for adjudication is made especially evident
   by the ongoing action in Delaware. In that action, the government has taken
   positions similar to those that Walmart challenges here, but Walmart itself
   stresses that there are differences. Walmart points to Declaration D, which
   states that pharmacists are not required to “document in writing why filling
   a prescription was appropriate.” “[F]or reasons unknown to Walmart,” the
   government has advanced no directly contrary position in the Delaware
   litigation.12 Even where the government’s theories basically match those
   challenged by Walmart, there are subtle differences—for instance, Declara-
   tion A states that pharmacists are liable only when they knowingly fill an ille-
   gitimate prescription or knowingly “abandon all professional norms.” As it
   turns out, the government disagrees with only the second half of the



           11
                The one outlier, Declaration I, is a statement of administrative law.
           12
            It is not that the government’s complaint does not reach the issue. The govern-
   ment does allege a documentation requirement by pharmacists who fill prescriptions, but
   only where those prescriptions present “red flags.” See Complaint at 25, United States v.
   Walmart Inc., No. 20-cv-1744, ECF No. 1.




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                                          No. 21-40157


   declaration—it concedes in its complaint that the filling of an ineffective pre-
   scription must be knowing to be punishable.13
          Those discrepancies illustrate the peril of treating Walmart’s request-
   ed declarations as constituting a ripe case or controversy. Even courts that
   are relatively relaxed in their ripeness analysis stress the importance of an
   unequivocally expressed position by the government. See N.H. Hemp Coun-
   cil, Inc. v. Marshall,
203 F.3d 1, 5
 (1st Cir. 2000); Monson v. DEA,
589 F.3d 952, 958
 (8th Cir. 2009). When this case was brought, the government had
   no unequivocal position, but now it has one—and that position is, by Wal-
   mart’s own telling, materially different from the one Walmart challenges.
          At its core, ripeness is a matter of timing that serves to prevent courts
   from entangling themselves in cases prematurely. See, e.g., Thomas v. Union
   Carbide Agric. Prods. Co.,
473 U.S. 568, 580
 (1985). If it was not clear when
   the case was brought, it is certain now that the lack of a clear position on the
   part of the government rendered the case premature at that time. Because it
   challenges a series of positions that the government does not quite take, Wal-
   mart fails to show the “actual controversy” that is needed for a declaratory
   judgment to be fit for judicial decision. See Orix,
212 F.3d at 896
.

                                                C.
          Turning to the second half of the ripeness balancing test, the existence
   of the Delaware litigation eliminates, or at least greatly reduces, the hardship
   that will be placed on Walmart by withholding consideration of this suit.
   Walmart alleges that the requirements the government seeks to impose are
   far more exacting than those called for by many state governments and
   private-sector actors, with the result that complying with the federal require-



          13
               See Complaint at 26, United States v. Walmart Inc., No. 20-cv-1744, ECF No. 1.




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                                         No. 21-40157


   ments exposes it to liability under state law. That hardship may well have fit
   within the pattern recognized by ripeness cases: Walmart could comply with
   the alleged federal rules only by exposing itself to enforcement action. 14
           Now, however, Walmart has the ability to test the government’s regu-
   latory position in court by raising its theories as defenses in the Delaware
   action. Though the proposed declarations here are somewhat broader than
   the government’s position in the Delaware litigation, that same discrepancy
   indicates the problem with Walmart’s position. Legal theories not accepted
   or pursued by the government cannot create cognizable hardship for pur-
   poses of ripeness. See Ohio Forestry Ass’n, Inc. v. Sierra Club,
523 U.S. 726, 733
 (1998). Walmart may fear that the Delaware litigation will proceed more
   slowly than this one would or that the court in that jurisdiction may be less
   sympathetic to its position, but those are not the “adverse effects of a strictly
   legal kind” that are necessary to show that withholding of consideration by
   this court imposes hardship on Walmart.
Id.
           In addition to providing Walmart with an avenue to test its theories,
   the Delaware suit reduces the likelihood of future prosecution. Cases assess-
   ing standing in pre-enforcement cases, which tracks closely with ripeness, see
   Susan B. Anthony List v. Driehaus,
573 U.S. 149
, 167 (2014), often ask whether
   the threat of enforcement is sufficiently “credible,”
id. at 161
, or “clear,”
   N.H. Hemp,
203 F.3d at 4
. The bringing of the Delaware suit proves that,



           14
              Compare Abbott Labs., 387 U.S. at 152–53 (finding ripeness where compliance and
   noncompliance are both potentially costly), with Toilet Goods Ass’n v. Gardner,
387 U.S. 158, 164
 (1967) (not finding ripeness where “no advance action is required” to comply with
   a regulation). This analysis is limited to Declarations A through F. Declarations G and H
   concern the obligations of distributors, whereas Walmart has not distributed opioids since
   2018. Declaration I is a truism of administrative law. Even before the Delaware litigation,
   Walmart could have safely ignored whatever position the government took on those issues
   without exposing itself to new liability.




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Case: 21-40157       Document: 00516142688              Page: 16       Date Filed: 12/22/2021




                                         No. 21-40157


   when this case was filed, enforcement was indeed impending. When consid-
   ered from the standpoint of the present, however, the suit’s existence also
   suggests that future enforcement is unlikely.15
           The government has made its move; it would be unusual for it to bring
   a second action against the same defendant on similar theories until after the
   current case is decided. There is thus no clear or credible threat of future
   prosecution, further undermining the position that withholding review cre-
   ates hardship for Walmart. Because the case is not fit for judicial review, and
   withholding consideration imposes no substantial hardship on Walmart, this
   action presents no ripe case or controversy.
           The dismissal for want of jurisdiction is AFFIRMED.




           15
            Cf. Reg’l Rail Reorganization Act Cases,
419 U.S. 102, 140
 (1974) (concluding that
   the circumstances at the time of decision, not the time of the district court’s decision,
   governed ripeness analysis).




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Case: 21-40157     Document: 00516142688           Page: 17   Date Filed: 12/22/2021




                                    No. 21-40157


   Patrick E. Higginbotham, Circuit Judge, concurring:

          As addressed in Section IV, the pending litigation in this case answers
   concerns of our jurisdiction; Section III is unnecessary and therefore I
   respectfully would not offer explanations of why, in Section IV’s absence, the
   case would fail. I concur in Sections I, II, and IV, and in the judgment.




                                         17